Adenoma, Bile Duct Clinical Trial
Official title:
Efficacy and Safety of Endobiliairy Radiofrequency (Probe Habib TM EndoHPB) for the Destruction of Residual Endo Biliairy Dysplastic Buds After Endoscopic Ampullectomy: Prospective Multicenter Study
The purpose of the study is to assess the efficacy and morbidity of biliairy radiofrequency ablation for the treatment of dysplastic endobiliairy residual lesions (low-grade dysplasia or high-grade dysplasia) after endoscopic ampullectomy for ampullary adenoma.
Neoplastic lesions may persist at the termination of the common bile duct or pancreatic duct, after endoscopic ampullectomy for adenoma. Such lesions conduct to a difficult therapeutic problem because surgery (pancreaticoduodenectomy or trans-duodenal resection) has significant morbidity compared to non-invasive lesions. The use of endoscopic destruction techniques of dysplastic lesions, including radio-frequency could be an interesting alternative to reduce the risk of invasive cancer with less morbidity. Ablation with radio-frequency (RF) is a technique of local tissue destruction in use in many applications, percutaneously or intraoperatively for the treatment of hepatocellular carcinoma smaller and more recently for the endoscopic treatment of high-grade dysplasia of Barrett's esophagus. An RF probe has been developed for an endo-biliary application (Habib EndoHPB, Emcision) and 2 preliminary studies have reported the use in humans, in the indication of unresectable cholangiocarcinoma. These two studies have confirmed the feasibility of the technique, with few side effects and probable anti-tumor efficacy demonstrated by expanding the area of stenosis after treatment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03270046 -
The Effects of An Addition of Water Enema to PEG for Colon Preparation
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N/A |